Overview:This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered:History and background of U.S FDA Laws and RegulationsClassify Your DeviceChoose the Correct Premarket Submission for your deviceCompile the Appropriate Information for your Premarket SubmissionAuthor and Prepare your Premarket SubmissionSubmit your Premarket Submission to the FDAInteract with FDA Staff during Review and ApprovalComplete the Establishment Registration and Device Listing Why should you attend :The U.S.

FDA regulatory 510(k) clearance and Premarket Approval (PMA) process is considered a most stringent and complex. Only a good knowledge of U.S. FDA laws, regulations, and requirements is not sufficient to win a clearance/approval. You are required a proper training on how to set and state regulatory arguments for your device in a most convincing manner to the U.S. FDA reviewer. This 2 days training seminar will walk you through building process of a reader's friendly but resounding premarket submission and also give you tips and suggestions on how to work effectively with the U.S.

FDA Premarket RegulationsHistory and background of U.S FDA Laws and RegulationsHow to Classify Your DeviceChoose the Correct Premarket Submission for your deviceLecture 2:Premarket Notification 510(k)Applicable Laws, Regulations and Requirements for 510(k)Decide Type of 510(k)Compile the Appropriate Information for 510(k)Format and Content of your 510(k)Lecture 3:Premarket Notification 510(k) - continueSuggestions on What to Include or Exclude into your 510(k)Tips on authoring a reader's friendly and convincing 510(k)Critical Review of your prepared 510(k) for acceptabilityLecture 4:Premarket Notification 510(k) - continueDetermine risk and contingency plan for potential questions form the reviewerPoints to Consider - Submit your 510(k) to FDAInteract with FDA staff during review and clearance of your 510(k) Day 2 ScheduleLecture 1:Premarket Approval (PMA)Applicable Laws, Regulations and Requirements for PMADecide Type of PMACompile the Appropriate Information for PMAFormat and Content of your PMASuggestions on What to Include or Exclude into your PMATips on authoring a reader's friendly and convincing PMALecture 2:Premarket Approval (PMA) - continueCritical Review of your prepared PMA for acceptabilityDetermine risk and contingency plan for potential questions form the reviewerPoints to Consider - Submit your PMA to FDAInteract with FDA staff during review and clearance of your PMALecture 3:Investigational Device Exemption (IDE)Applicable Laws, Regulations and Requirements for IDEPurpose and Use of Pre-IDE to your advantageCompile the Appropriate Information for IDEFormat and Content of your IDESuggestions on What to Include or Exclude into your IDETips on authoring a reader's friendly and convincing IDELecture 4:Post Market Requirements for Medical DevicesQuality System (QS) Regulation/Medical Device Good Manufacturing PracticesMandatory Medical Device Reporting (MDR)Recalls, Corrections and RemovalsMedical Device TrackingPost Market Surveillance Studies (PSS) mandated under section 522 of the Federal Food, Drug and Cosmetic ActPost-Approval Studies (PAS) mandated as a condition of approval of a premarket submission - mostly premarket approval (PMA) applicationPoints to consider - Third Party Inspection by Accredited Persons Program limited to manufacturers who meet certain conditions Speaker:Subhash R Patel,Regulatory Affairs & Quality Compliance Consultant, MD Reg Consulting, LLC, Subhash Patel is an accomplished Regulatory Affairs Professional offering 30 plus year of experience in authoring, preparing and submitting more than 150 successful premarket submissions to U.S.

FDA. He brings his expert knowledge and hands-on experience in developing a robust premarket submission that secures clearance or approval from U.S. FDA. He offers valuable tips and suggestions on "what works and what doesn't" form his own experience. He has presented numbers of technical papers at conferences and conducted plentiful training seminars in various countries.He is a Fellow of world's renowned Regulatory Affairs Professional Society (RAPS) and holds professional recognition as a Regulatory Affairs Certified (RAC) form RAPS.

He also holds professional certification as Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE) form American Society for Quality (ASQ). His educational background includes BS degree in Mechanical Engineering and BS degree in Chemistry. He founded MD Reg Consulting, LLC based in New Jersey, USA to serve medical device industry clients in all aspects of global regulatory affairs and specific to their needs.